1 regulation of drug research. 2 what is drug research? there are two approaches: a wider and a...
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Regulation of drug research
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What is drug research?
There are two approaches: a wider and a pragmatic one
The latter make a difference between „research of drugs” and „research of biologically active substances”
Before we start…
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Research of drugs
• marketed drug product as soon as possible
• are taken into account, building the research on them
• what is necessary for registration
Research of biologically substances
• publication, dissertation…
• Are not taken into account, only the rules of the „Art of academic research”
• What is interesting
aim
the drug registration/authorisation rules
subject
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Consecutive phases of real drug research
„molecule research”
Fixing the quality of the
API
animal toxicology
animal pharmacology
dosage-form development
Fixing the API manuf.
technology
Fixing the dosage-form manuf. technology
human clinical trials
registration (authorisation)
Time scale (start)
API = active pharmaceutical ingredient
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Can drug research be regulated at all?
• Its some fields by laws, directly– animal experiments: general principles and quality assurance of some
studies
– human clinical trials• Other fields by laws only indirectly a piece of law specifies
how the documentation should be compiled (e.g. listing chapters and
types of experiments) and submitted for registration, but directly only by „soft law” (=guidelines)
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Research for a new drug:New API found• synthesis• manufacture• physical and chemical quality• Decomposition routesAnimal experiments• pharmacology• toxicologyDrug product development• Composition (its logics)• manufacture• chem. and dosage-form control• stability Clinical trials on humans direct regul.Dossier structure, information sheets, authorisation direct regul.
„chemical dossier” indirect regul. direct regul. (GMP)
„non-cinical dossier” indirect regul. direct regul. (GLP)
„chem.-pharmaceutical dossier” direct regul. (GMP)
indirect regul.
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Regulation of chemical-pharmaceutical research
• Indirect regulation will be discussed in connection with the topic „registration, authorisation”
• The same for dossier structure
• Direct regulation: GMP: when we discuss „manufacture”
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Regulation of animal experiments
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Regulation of animal experiments
In many countries: Animal Protection ActDefinition of „animal experiment” and „torture of
animals”• Killing an animal: if absolutely necessary, but in
narcosis• Torture of animals is forbidden• Some countries: except
– excirbation of goos feather (for bed-clothes)– crumming of gees or ducks (for goos liver)
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Regulation of animal experiments, 2
• Before starting, you should check whether it is regulated in your country!
• If regulated, is the „experimental animal” defined? (E.g.: live vertebrates)
• Is the purpose limited? (E.g. for drug research, other scientific and educational purposes only, but not for cosmetics)
• Is the number regulated? (E.g. the „lowest possible”)• Do you need any authorisation/notification to conduct
animal experiments, or it is completely free?
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A regulated quality assurance system, required for e.g. experimental toxicology in many developed
countries:
Good Laboratory Practice GLP
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GLP
• What is GLP: a quality assurance system (to be delt with in the next semester)
• When should GLP be applied: for all non-clinical health and environmental safety studies (including toxicology in drug research)
• Health and environmental safety studies: when any new substance is innovated, its further safe handling several data are needed, e.g. melting point, flashing point, toxicity, etc.!
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Thus, GLP:
it is a quality assurance system dealing with the organisation and conduct of non-clinical health and environmental safety studies, including their planning, execution, control, documentation, archiving and the issue of their final report
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We said „new substances”. What kind of new substances applies
GLP?
• drugs (both human and veterinary)
• phyto protective agents
• industrial/household „chemicals”
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What „studies” are under GLP?
• Physical and chemical• Toxicity (acut - chronic, reproductivity, foetal,
carcinogenicity, local tolerance, toxicokinetics)
• mutagenicity• ekotoxicology in aquatic and terrestrial
organisms(continued)
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What „studies” are under GLP? (continued)
• Degradation, bioaccumulation in water, soil and air
• Phyto protector residues• Effects on micro-climas and natural
ecosystems• Analytical and clinical studies if connected to
any listed above (clinical: veterinary!)
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Animal experiments used for drug research…
• …more exactly: the non-clinical safety and efficacy studies (therapeutic benefit/risk)
• Are regulated by numerous guidelines („soft law”) – these will be mentioned in the part dealing with registration/authorisation!
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Next topic:Regulation of human clinical trials
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Recognise:• In the non-clinical part we used the terms „study” or
„test” or „experiment” on animals• In the human clinical part the similar activity is called
„trial”!• This is not a play with the words! The language of the
regulation would like to underline that, when a drug is used first in humans, there are many safeguard measures and we are almost sure the result will be positive or at least does not harm the subjects!
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Exam topic
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Regulation of drug research
• Direct and indirect regulation (examples, please)
• The role of the „soft law”
• Regulation of animal experiments
• What is GLP? When should it be applied? (Definition, types of studies and substances to be studied)
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